NRx Pharmaceuticals Reports Q3 2025 Results and Advances Key Regulatory Programs for Depression Treatments

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) reported third-quarter 2025 results while highlighting substantial progress across its clinical development programs, marking the company's initial revenue-generating activities alongside key regulatory advancements for its depression treatments. The company emphasized expanded Fast Track status and an active Expanded Access program for NRX-100 in suicidal depression, continuing advancement of its New Drug Application supported by large-scale real-world ketamine data. The Abbreviated New Drug Application pathway for its preservative-free ketamine KETAFREE remains on track for a second-quarter 2026 Generic Drug User Fee Amendments date, with Food and Drug Administration communication indicating no major deficiencies in the revised ANDA filing.

Ongoing efforts to remove benzethonium chloride from commercial ketamine formulations represent a significant safety initiative within the pharmaceutical industry. For NRX-101, the company initiated its NDA with Breakthrough Therapy Designation and rolling review, supported by real-world evidence demonstrating that D-cycloserine more than doubles the antidepressant and antisuicidal effect of Transcranial Magnetic Stimulation. A confirmatory phase 3 trial is scheduled for early 2026, providing additional clinical validation for the treatment approach. The company continues expanding its HOPE delivery platform with additional facilities planned in Florida, enhancing patient access to these innovative therapies.

NRx Pharmaceuticals develops therapeutics based on its NMDA platform for central nervous system disorders, specifically targeting suicidal depression, chronic pain, and PTSD. The company's pipeline includes NRX-100, preservative-free intravenous ketamine that has received Fast Track Designation for treatment of Suicidal Ideation in Depression including Bipolar Depression, and NRX-101, an oral D-cycloserine/lurasidone combination that has been awarded Breakthrough Therapy Designation for suicidal bipolar depression. Additional information about the company's developments is available through their corporate communications at https://www.nrxpharma.com. The latest updates relating to NRXP are accessible in the company's newsroom at https://ibn.fm/NRXP, while comprehensive coverage of biomedical developments can be found at https://www.BioMedWire.com.